Thursday, February 25, 2021
Nexus Spine, a developer of medical instruments and implants for spinal surgery, today announced the broad availability of its novel compliant-mechanism based systems for use in spinal surgeries; specifically, PressON, which is a patient-specific fixation system for stabilizing the human spine, and Tranquil, which is a flexible titanium device for interbody fusion.
The breakthrough offered by Tranquil and PressON is the novel application of compliant mechanism technology, allowing well-established biocompatible materials like titanium to behave as organic human tissue, on a microscopic level. This breakthrough enables bio-friendly synthetic materials that have long been shown to perform well in the body to now perform more like the surgically treated tissues. Since 2015, Nexus implanted the devices in hundreds of patients and has found faster healing and with less pain.
Compliant mechanisms mimic nature by providing motion and force transmission through flexibility rather than from traditional rigid-body joints. Nexus Spine is pioneering the application of microscopic compliant mechanisms to the human spine. Through the use of modern mathematical modeling, 3D finite element analysis, and 3D printing, Nexus is drastically improving the way that spinal implants perform.
"Nexus Spine has demonstrated improved clinical outcomes, decreased costs, and simplified use by leveraging our novel compliant mechanism engineering expertise and intellectual property. Our advanced technology products have been shown to decrease pain, speed healing, and reduce the cost of care," said David Hawkes, president at Nexus Spine. "Our proprietary devices reduce surgical time and provide surgeons maximum versatility to accommodate patient-specific needs, increasing the likelihood of long-term success for patients."
Through patented compliant mechanism-based compositions and unique applications of 3D printing, Nexus Spine's Tranquil device is the only technology to obtain the optimal combination of stiffness and porosity for the spine to encourage rapid spinal bone growth, resulting in faster healing and less pain.
Tranquil is a flexible, bone-replicating, interbody device, made of bio-friendly titanium that is shaped and engineered to act just like spinal bone, with the same stiffness as human spinal trabecular bone -- 1/10th as stiff as the devices that have traditionally been used in spine surgeries.
"Titanium has been used in orthopedic surgery for decades, with a stellar history. The key to better outcomes, however, is going further and getting titanium to act like spinal bone. Any spinal implant company can 3D print what is essentially a block of titanium with a fancy shape and a lot of little holes, and that is happening widely right now," said Gary L. Crocker, president of Crocker Ventures. "Only Tranquil achieves the right combination of implant stiffness, pore size, surface area, texture, and material. Other products simply can't."
Unlike in the 96% of spine surgeries where the space between the vertebrae subsides -- or collapses -- more than 2mm around the spacers in just the first six weeks after an operation, Tranquil eliminates measurable subsidence, to substantially improve clinical outcomes in patients, including those who are the least likely to typically experience healthy bone growth.
"I've noticed that patients with Nexus Spine's interbody spacers suffer less subsidence following their surgeries, meaning bone is not collapsing around the metal inserts between each vertebra as much as with traditional spacers," said Dr. Jeffrey S. Hoskins, an orthopedic surgeon at the Orthopedic Institute of Dayton.
Due to the bio-friendly, bone-like qualities of Tranquil, it is less expensive to use than traditional spacers. A primary cost saver is the elimination of costly supplemental biologics to stimulate bone growth. A key advantage that clearly emerges after studying the post-operative data from hundreds of Tranquil patients is that healing time, as defined by spinal stability, is months faster.
"I've used Tranquil in more than 75 surgeries and have seen remarkable results as my patients have experienced less pain and better outcomes," said Dr. John Edwards of Intermountain Healthcare. "Unlike traditional implants, tranquil interbody spacers work with patients' bodies, promoting bone growth, increasing flexibility and eliminating subsidence, which can oftentimes nearly undo the work done by the surgery."
PressON is a unique, patient-specific spinal fixation system that eliminates the painful stresses caused by other systems.
PressON employs compliant-mechanism technology to exactly match the patient's specific needs, eliminating spinal rod-bending and other painful persuasion techniques currently used in spinal surgeries. PressON can exactly match the shape of even the most complex spinal surgeries. As a bonus, PressON is substantially faster and easier to apply, as it can be installed in 1/16 the amount of time. Additionally, it is much smaller than other predicate devices -- roughly one-third the volume – thus decreasing soft tissue irritation and decreasing the incision to half the length, further reducing postoperative pain and recovery time.
"Compliant mechanisms have made it possible for our engineers to get less metal to do more for patients," summarized Hawkes. "Traditional rod systems require larger wounds and more tissue retraction and more surgical instruments, which lengthens the surgery, increases the likelihood of infections and causes pain. PressON is patient-specific, eliminating rod-bending, rod-persuasion and painful unintended stresses. Furthermore, PressON is smaller, faster, and stronger."
"I had dealt with back pain and herniated disks for years," said Adam Echols, a patient who underwent a spinal fusion using Nexus Spine products in 2019. "At the recommendation of my surgeon, we went with the Tranquil spacer. The difference has been incredible and the pain I'd previously experienced and accepted as a daily part of my life has been completely eliminated."